Biologics Manufacturing Specialist

3 days ago


Framingham, Massachusetts, United States Replimune, Inc. Full time

Job Overview

At Replimune, Inc., we are seeking a skilled Biologics Manufacturing Specialist to join our team. As a key member of our manufacturing operations, you will be responsible for providing technical support for oncolytic virus manufacturing, including life cycle management of commercial processes.

Estimated Salary: $120,000 - $180,000 per year (depending on location and experience)

About the Role

As a Biologics Manufacturing Specialist, you will work closely with cross-functional teams to troubleshoot issues with drug substance and/or drug product processing technologies and equipment. You will provide effective life cycle management through CAPA/Change Control execution and deviation resolution, and drive continuous improvement in our cGMP process steps.

Key Responsibilities

  • Support oncolytic virus drug substance and/or drug product manufacturing process technology transfer and post-transfer manufacturing support.
  • Provide technical expertise in troubleshooting issues with drug substance and/or drug product processing technologies and equipment.
  • Provide effective life cycle management through CAPA/Change Control execution and deviation resolution.
  • Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through change requests or technology builds for commercial processes.
  • Monitor commercial process performance and perform evaluation of continuous process verification data and trends.

Requirements

To be successful in this role, you will need a Master's degree in chemical or biomedical engineering or equivalent and 0-3 years of related work experience, or a Bachelor's degree in chemical or biomedical engineering or equivalent and 2-5 years of related work experience.



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